Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Renal failure
Study Overview
Brief Summary
The outbreak of Covid-19 started several clinical trials and treatment experiments all over the world in the first months of 2020. This study investigates reports of adverse events related to used molecules, including but not limited to protease inhibitors (lopinavir/ritonavir), chloroquine, azithromycin, remdesivir and interferon beta-1a. Analyses of reports also include the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •all patients treated for Covid-19
Exclusion Criteria
- •Chronology not compatible between the drug and the toxicity
Arms & Interventions
Patients treated for Covid-19
Intervention: Any drug used to treat Covid-19 (Drug)
Outcomes
Primary Outcomes
Renal failure
Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Secondary Outcomes
- Heart failure(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- EKG disturbance(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Hepatic failure(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Anemia(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Leucopenia(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Vascular disease(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Toxidermia(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Osteoarticular adverse event(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Death(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Acute respiratory distress syndrome(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
- Pulmonary embolism or pulmonary hypertension(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
Investigators
Lee S Nguyen
Principal Investigator
Groupe Hospitalier Pitie-Salpetriere